Chief Medical Device Design Specialist

2 weeks ago


Ballerup, Ballerup Kommune, Denmark GN Store Nord AS Full time

About the Job

In this role as Design Controller, you will be a crucial part of GN\'s mission to Bring People Closer. Your primary responsibility will be to ensure compliance with the corporate Quality Management System and regulated standards in Medical Device SW projects. You will plan and implement Design Control deliverables, facilitating design reviews, risk assessments, and audit processes.

About the Team

You will be part of the R&D Hearing team in Poland, a global team developing software for Hearing Instruments. The team collaborates closely with colleagues in Danemark, US, and India. As Design Controller, you will support Cloud and FSW teams.

About the Role

You will:

  1. Plan and coordinate completion of Software Development deliverables in compliance with corporate QMS and IEC 62304
  2. Facilitate design reviews, participate in risk assessments, etc. to ensure compliance
  3. Work with Corporate Quality and internal stakeholders to streamline, optimize, and improve compliance documentation
  4. Oversee audit processes, including findings from GN Online Services and Fitting Software
  5. Improve and optimize Design Control process

About You

We are looking for someone with:

  1. 5+ years in Medical Device Industry
  2. Proficiency in English
  3. Solid understanding of Medical Device Design Control and regulations (21 CFR 820.30, ISO 13485, ISO 14971, IEC 62304, IEC 62366, 21 CFR 820.30)
  4. Demonstrated initiative; results-oriented; willingness and ability to institute change
  5. Ability to communicate effectively in a multi-discipline environment, and across cultures and levels of the organization
  6. Proficient verbal and written communication skills; including experience in writing and presentation skills
  7. BS in Engineering or Sciences

About Us

GN brings people closer through our leading intelligent hearing, audio, video, and gaming solutions. Inspired by people and driven by innovation, we deliver technology that enhances the senses of hearing and sight. We enable people with hearing loss overcome real-life challenges, improve communication and collaboration for businesses, and provide great experience for audio and gaming enthusiasts.

About the Company Culture

GN\'s values of listen, challenge, and transform form our culture. We greet every day with energy, engagement, and enthusiasm, bringing our best selves and approaching problem-solving and challenges with a \"glass half full\" attitude. We\'re independent, but we also know when two heads are better than one. Our leaders are friendly, our teams are tight-knit, and we believe in the power of collaboration across every level of our organization.



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